A study on siddha formulation Seenthil Sarkarai and Mathan Thailam in children for Padarthamarai(Dermatophytosis)

Phase 2

Not yet recruiting

• Conditions: Dermatophytosis, unspecified,

• Registration Number: CTRI/2025/04/084861
• Lead Sponsor: National Institute of Siddha

Brief Summary

BACKROUND:

Dermatophytosis(ICD-11-1F28)isthemostimportant groupofsuperficialfungalinfections caused bydermatophytes, which is a group of fungi that are capable of growing by invadingthe keratin of skin, hair, and nail for obtaining nutrients. There are several reports on intracontinental variability of the global incidence because of the change in climatic condition across the world.[1]According to World Health Organization (WHO), the prevalence rate of superficial mycotic infection worldwide has been found to be 20-25%. [2] It is more prevalent in tropical and subtropical countries like India where the heat and humidityis high for most part of the year. [3]Environmental factors include high temperature and relative humidity, which provide conditions favourable to fungal dispersion and development. Sociodemographic factors, such as poor socioeconomic status, promiscuity, prolonged contact withanimals,andpoorhygieneconditions,arealsoconducivetotheincidenceandpropagationof mycotic infections. [4]



DermatophytesincludeseveralgeneralikeTrichophyton,MicrosporumandEpidermophyton.SomecommonorganismsincludeTrichophytonsudanese,Trichophytontonsurans,Trichophyton verrucous,Trichophyton rubrum, and Microsporum canis. [5] *Padarthamarai* is one of the common skin disease(kuttam).In Siddha concept,kuttam is a broad term used to denote skin diseases. *Yugi muni* classified skin disease into 18 types. *Padarthamarai* can be equated to the most important cutaneous fungal infection due to dermatophytes. Tinea is a common fungal infection which often spreads from one person to another easily through skin contact. Children are more prone than adults since creating awareness among them may be difficult and they get easy skincontact in common places like schools. Also fungal infections are being resistant to medicines in recent days due to frequent use of antibiotics. I have chosen *“PADARTHAMARAI*” (ISMT4.12.55) as my dissertation topic. Siddha texts describes that padarthamarai is an annular skin lesion in which patches are red in the centre and darkredonedgesresemblingthepetalsoflotusso.Itisalsocalledas*Pundareegamkuttam*These symptoms are similar to the symptoms of dermatophytoses of modern literature ,Antifungal propertypertainingdrugsareusedtotreatpadarthamarai.Consideringandreviewingalltheabove *Seenthil sarkari* as internal medicine and *Mathan thailam* as external application is chosen for *PADARTHAMARAI* in children for my dissertation.

OBJECTIVE:

To evaluatethe therapeuticeffectiveness of the*Seenthilsarkarai*asinternaland*Mathan thailam* as external in the management of *Padarthamarai* (Dermatophytosis) in children.

METHODOLOGY:

**Studydesignandconduct ofthestudy** Studytype:Anopen-label,Single-arm,Single-centrephaseIIclinicaltrial.

Studyplace:AyothidossPanditharHospital,NationalInstituteofSiddha,TambaramSanatorium, Chennai-47



Studyperiod: 18Months



PopulationAndSample**:** 6-12agegroupfulfillingalltheinclusioncriteriaandpassingtheexclusioncriteriamentionedbelow



Number of Patients : 30 participants



INCLUSION CRITERIA:

1.    Age: 6-12 years

2.    Sex: Both male andfemale children.

3.    Participants with clinicalfeatures of *Padarthamarai* (Dermatophytosis)

4.    NRS below 6 points(moderate) and CDLQI below 10 score(moderate) will be included

EXCLUSION CRITERIA:

1.    Known cases of Skin diseaseslike contact dermatitis, vitiligo, psoriasis, atopicdermatitis.

2.    Other diseases or medications that might directlyinterfere in the study.

3.    Diabetes mellitus-Type 1 inparticipants.

EXPECTED OUTCOME:

Reduction of signs and symptomsof Dermatophytosis by NRS 0 point (no itching) and CDLQI 0 score (no effectson participant’s life) after treatment is expected in studyparticipants.

RESULTS AND DISCUSSION:The Result will be statistically analysed and reported.

KEYWORDS: Seenthil Sarkarai, Mathan Thailam,Padarthamarai,Dermatophytosis

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-15
• Study Start: 2025-04-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Participants with clinical features of Padarthamarai (Dermatophytosis) NRS below 6 points(moderate) and CDLQI below 10 score(moderate)will be included.

Exclusion Criteria

• Known cases of Skin diseases like contact dermatitis,vitiligo,psoriasis,atopic dermatitis.
• Other diseases or medications that might directly interfere in the study Diabetes mellitus -Type 1 in participants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of signs and symptoms of Dermatophytosis by NRS 0 point (no itching) and CDLQI 0 score (no effects on participant’s life) after treatment is expected in study participants.	Reduction of signs and symptoms of Dermatophytosis will be assessed after the period of 48 days

Trial Locations

Locations (1)

Ayothidoss Pandithar Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Ayothidoss Pandithar Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr PBhavatharani

Principal investigator

09361947973

bhavatharanipugazh1999@gmail.com